Delays for the regulatory filings of its Covid-19 vaccine NVX-CoV2373 (NUVAXOVID) have meant Novavax (NVAX) has been unable to get its offering out to the public yet. You would think that with other leading players firmly planted in the public and health policy makers’ consciousness, maybe the opportunity has already passed for last year’s outstanding performer.
However, in late-stage studies, the vaccine’s data has shown to be just as good as those of the leading approved vaccines. With the EUA filing slated for Q3, the vaccine the subject of an EMA rolling review and being assessed by other regulators – notably in the U.K. and India – the catalysts are piling up.
B.Riley’s Mayank Mamtani has long banged the drum for Novavax’s potential vaccine, and in his latest endorsement highlights the recent conversation around the EUA approved vaccines’ “safety and durability of protection.”
As for the latter, while data showing the approved vaccines’ “waning” effectiveness – either since the initial primary jabs or from the emerging variants – remains “limited,” the analyst believes the talk around the “need for boosters” is likely to also include the impact on “high-risk population segments,” including the immunocompromised, the elderly populace and frontline workers.
“Specifically,” Mamtani notes, “There is also the need to reconcile mixed evidence on kinetics of immune response among mRNA vaccines’ 6-12 month follow-up data relative to JNJ’s 8-month follow-up data published on 7/15.”
As for the former, Mamtani says the CDC and FDA remain “highly diligent” around the approved vaccines’ safety profile in real-world use cases. This is evident with the label updates with relevant warning language for JNJ’s vaccine regarding the risk of Guillain-Barré syndrome (GBS), and young adolescents at risk of heart inflammation from PFE/MRNA’s mRNA vaccines.
Mamtani, therefore, thinks Novavax’ vaccine is well-positioned to benefit when it finally enters the market.
As such, the 5-star analyst said, “We believe the potential imminent resolution of NVAX’s challenges around global regulatory filings and manufacturing scale-up activities, also explaining continued volatility, presents an underappreciated multi-year, global opportunity set based on NVAX garnering meaningful market share in the unvaccinated (near-term) and the vaccinated populations globally, with the latter notably benefiting from datasets generated in COM-COV2 ‘booster’ study and recently initiated Ph. I/II study for C-19/influenza combination vaccine product (NCT04961541).”
All in all, Mamtani reiterated a Buy rating for NVAX shares, backed by a $286 price target. The implication for investors? Upside of 53%. (To watch Mamtani’s track record, click here)
Tuning now to the rest of the Street, where the average price target is a more modest $249.60, yet still suggests one-year gains of ~19%. Overall, the stock has a Moderate Buy consensus rating, based on 4 Buys vs. 2 Holds. (See NVAX stock analysis on TipRanks)
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Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.